Device class
Class II
Regulation 882.5891
Total clearances
12
2020-09-29 → 2026-04-16
Definition
What is Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Classification details
Medical specialty
Neurology
Regulation number
882.5891
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 64550 |
CPT
|
— |
High
|
Application of surface (transcutaneous) neurostimulator; standard code for TENS migraine treatment |
| 97032 |
CPT
|
— |
Medium
|
Therapeutic modality; transcutaneous electrical nerve stimulation (TENS) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-16 |
K254216 |
Hinge Health, Inc.
|
Enso for Migraine |
| 2024-11-06 |
K242719 |
Nu Eyne Co., Ltd.
|
ELEXIR 2.0 (ALLIVE3) |
| 2024-07-18 |
K234029 |
Cefaly Technology
|
CEFALY Connected - OTC, CEFALY Connected - Rx |
| 2024-06-11 |
K232749 |
Ybrain, Inc.
|
DOOPANG |
| 2024-06-03 |
K233751 |
Soterix Medical, Inc.
|
Milieve (YPS-301BD) |
| 2024-02-26 |
K230782 |
Wat Medical Technology, Inc.
|
TENS device-HeadaTerm 2 (Model: YF-HT2) |
| 2022-12-13 |
K212071 |
Cefaly Technology
|
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx |
| 2021-08-02 |
K212106 |
Neurolief , Ltd.
|
Relivion |
| 2021-07-30 |
K211380 |
Nu Eyne Co., Ltd.
|
Elexir |
| 2021-06-17 |
K210364 |
Shenzhen Dongdixin Technology Co., Ltd.
|
Migraine Tens Digital Pain Reliever |
| 2021-02-16 |
K203419 |
Neurolief , Ltd.
|
Relivion |
| 2020-09-29 |
K201895 |
Cefaly Technology
|
Cefaly Dual |